Status:
RECRUITING
Searching for Novel Therapeutic Approaches in Migraine Patients Resistant to Treatments
Lead Sponsor:
IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborating Sponsors:
University of L'Aquila
Conditions:
Migraine Disorders
Chronic Migraine
Eligibility:
All Genders
18-75 years
Brief Summary
Primary working hypothesis is that NON-responders to mAbs bear a dysfunction of the endocannabidiome system (eCBome), as suggested by pre-clinical and clinical data by our group. They will be identif...
Detailed Description
Monoclonal antibodies directed against the calcitonin gene related peptide pathway (mAbs) have recently become available as the first targeted-therapy for migraine prevention. Despite their revolution...
Eligibility Criteria
Inclusion
- male and female patients aged 18 to 75 years
- diagnosis of episodic migraine or chronic migraine according to ICHD-3 criteria
- for episodic migraine: 8-14 monthly migraine days in the previous 3 months
- diagnosis of resistant migraine, defined by having failed at least 3 classes of migraine preventatives and suffer from at least 8 debilitating monthly headache days for at least 3 consecutive months
- patients naive to CGRP targeting treatments
Exclusion
- history of major psychiatric or other neurological conditions
- diagnosis of other primary or secondary headache disorders (only sporadic tension-type headache is allowed if the patients can clearly differentiate between the 2 types of headaches)
- clinically significant medical conditions
- chronic pain conditions
- alcohol and/or drug abuse
- pregnancy or lactation
Key Trial Info
Start Date :
May 10 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06562400
Start Date
May 10 2023
End Date
May 1 2026
Last Update
August 20 2024
Active Locations (1)
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1
Headache Science & Neurorehabilitation Unit
Pavia, Italy, 27100